Details for New Drug Application (NDA): 020251
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The generic ingredient in ZANTAC 25 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 020251
Tradename: | ZANTAC 25 |
Applicant: | Glaxo Grp Ltd |
Ingredient: | ranitidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EFFERVESCENT;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Mar 31, 1994 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE, EFFERVESCENT;ORAL | Strength | EQ 150MG BASE/PACKET | ||||
Approval Date: | Mar 31, 1994 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EFFERVESCENT;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Apr 1, 2004 | TE: | RLD: | No |
Expired US Patents for NDA 020251
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